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Cardinal Health recalls AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

Recalled February 12, 2020 · FDA recall Z-1038-2020 · Cardinal Health

Hazard
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. · FDA Class II
Units
7,659,634 total units
Sold at
Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.

Description

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Product
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
Manufacturer(s)
Cardinal Health

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Cardinal Health recalls AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | RecallWatchUSA